How Long Will it Take FDA to Act on Public Citizen Avandia Recall Petition?

Austin Kirk

By Austin Kirk
Posted November 7, 2008


Last week a petition was filed by Public Citizen calling on the FDA to issue an Avandia recall as a result of serious and life threatening side effects associated with GlaxoSmithKline’s diabetes drug. No official response has been released by the FDA and it is unclear how long it will take the regulatory agency to respond to the petition.

Avandia (rosiglitazone) was approved by the FDA in 1999 for treatment of type 2 diabetes by controlling blood sugar levels. However, since May 2007, substantial concerns have emerged regarding a number of potentially fatal Avandia side effects.

The Public Citizen petition indicates that Avandia should be banned because the health risks outweigh any potential benefits it may provide. In addition to previously reported risks, like an increased risk of heart attacks, congestive heart failure, bone fractures and vision loss known as macular edema, Public Citizen pointed to new concerns about an association between Avandia and liver failure.

From a review of the FDA Adverse Event Reporting System, Public Citizen was able to identify at least 14 cases of Avandia induced liver failure, including 12 deaths.

Public Citizen is a prominent consumer advocacy group which represents over 80,000 consumers in the United States. The Health Research Group of Public Citizen has previously taken similar actions to push for regulations that protect the public against ineffective and unsafe drugs and medical devices.

In 2006, Public Citizen filed a similar petition with the FDA calling for a Black Box tendon rupture warning for Levaquin and other antibiotics belonging to a class of medications known as fluoroquinolones. However, it was not until July 2008, over two years later, that the FDA announced that they would require the manufacturers to add almost the exact same warnings that Public Citizen had requested.

Potentially hundreds of users could have suffered debilitating Levaquin tendon ruptures as a result of the drug makers’ failure to adequately warn about this risk and the FDA’s failure to act on the petition for two years.

Last year, following the emergence of concerns about the heart risks associated with Avandia, the FDA narrowly voted against an Avandia recall and allowed the drug to stay on the market with a black box warning about the risk of heart attacks and congestive heart failure.

Several experts who have advocated for a recall suggest that as many as 100,000 Avandia heart attacks could have been caused by side effects of the diabetes drug since it was first approved in 1999. With 10,000 Avandia prescriptions continuing to be filled every day, how many more people must suffer heart attacks, liver failure or death before the drug will be removed from the market?


The Avandia lawyers at Saiontz & Kirk, P.A. represent individuals throughout the United States who are pursuing an Avandia lawsuit after suffering a heart attack, heart failure, stroke, bone fracture, blindness, liver failure or death.

If you, a friend or family member suspect that an injury may have been caused by side effects of Avandia, request a free consultation and claim evaluation.

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